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Ann: ANP Updates on US Regulatory Plans for ATL1102 in DMD, page-148

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mac9

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14/08/21

20:43

Post #: 55292465
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Originally posted by Akki ↑

It was also viewed as virtually a certainty they would be granted FTD and then it didn't pass through the first round response. FDA has awarded it to basically all companies with experimental drugs in DMD past and present - Sarepta, Pfizer, FibroGen, Solid, Santhera, Wave, Summit, Catabasis etc etc all have / had Fast Track designation .... but 1102 gets held up ?

You also have to wonder they've sat on their hands for so long in getting the partial clinical hold lifted - maybe it just goes back to the bare bones approach and small purse, have to pick where thin resources go. Last update was in late 2017 after being granted approval for the greatly reduced dosage in IIa with plans to submit a complete response early '18 but ? Again probably just the thin resources and pushing the DMD through at low dose.

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To be fair, you are the only person I saw here putting forward that FTD was a certainty.
Not a lot in R&D in Biotech and also the FDA is a certainty.

ANP Price at posting: 17.0¢ Sentiment: Buy Disclosure: Held
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